Study groups
The research physician about this research
Für Deutschland: Bitte beachten Sie: Die Arzneimittelstudien finden im niederländischen Groningen statt. Sie müssen Englisch oder Niederländisch sprechen, verstehen und lesen können, um an einer Studie teilnehmen zu können.
Who can participate?
Note:
As a female you can only participate if you are not pregnant, not breast feeding, and meet one of the following conditions:
For males, there are no requirements regarding contraception.
WHAT IS THE COMPENSATION FOR THIS RESEARCH?
Travel expenses will be reimbursed based on the distance traveled (€ 0,21 net per kilometer) with a minimum of € 13 and a maximum of € 176,40 (840 kilometers) per round trip, regardless of the mode of transportation.
HOW LONG DOES THIS RESEARCH TAKE?
The trial consists of a total of 14 short visits, so there is no overnight stay in the research facility in Groningen. After that, the follow-up visit will take place.
Note: You must be available for all dates to be able to participate in this clinical trial.
Read more about the research
This trial investigates the blood levels of the study compound. It will be investigated how quickly and to what extent different compositions of the study compound are absorbed, transported, and eliminated from the body. It will also be investigated how safe the study compound is and how well it is tolerated.
The study compound will be injected under the skin (this is called subcutaneous administration) of the abdomen. We will compare two different administration methods: a syringe and a pen-injector. A pen-injector is a device that is developed to make injections more easy and convenient. They are for example used by diabetes patients to inject insulin.
The study compound has already been administered to patients with chronic kidney disease or rheumatoid arthritis. It has only been given to patients in a research setting. The current study will be the first study where the study compound will be given to healthy participants.
This trial is not intended to improve your health but is necessary for the further development of this compound. The trial will only take place after it has been approved by the Independent Ethics Committee (METC).
To check if you are eligible to participate a medical screening will take place before the start of the trial. Depending on availability, this can be performed in Groningen or Utrecht. This screening will take place within 4 weeks before the start of the clinical trial.
The trial consists of a total of 14 short visits, so there is no overnight stay in the research facility in Groningen. After that, the follow-up visit will take place.
You will receive the compound once. You will be given the compound as an injection under the skin (subcutaneous) of the abdomen. There are 3 different study treatments in this study. You will receive one of them. Which study treatment you will receive will be determined by drawing lots. You have an equal chance to receive each study treatment.
During the trial, blood will regularly be drawn and urine will be collected. You have to sign the form for approval of participation in the study before the screening starts. After the screening it will be announced whether you can participate.
Consumption of medication, alcohol, tobacco and other nicotine containing products is not allowed the day before the dosing visit, and is limited to 5 cigarettes or the equivalent per day. Also, before the start of the trial and when you are not staying in the research facility, there will be restrictions for these products.
All potential medicines can cause side effects. The compound has already been studied in patients with chronic kidney disease or rheumatoid arthritis. A possible side effect may be an infection, which may occur when bacteria, virus or other microorganisms enters a person’s body and causes harm. Signs of infection can be different, but often include fever, feeling very tired, and sweats or chills. Infections can also have no signs or signs that are so mild that you may not notice, but these infections will be shown by a blood test. We do not know how often these side effects may happen.
You should take into account that (serious) side effects may occur that are still unknown. In addition to unknown side effects, there is a (small) chance that an allergic reaction will occur. This can be caused by the study compound or other ingredients that are used to prepare the formulation. During the study, you will be under strict medical supervision. The doctors and investigators of ICON are always well-informed about the compound being studied. With this knowledge they can estimate the effects and side effects reasonably well.
You can participate in a trial a maximum of four times a year. There must be at least 30 days between two trials. Some trials have a longer waiting period.
During the trial, you may suffer from mild symptoms like headache or nausea. That may be caused by the medication. It might also be caused by needing to fast for the trial, for example. Those side effects are no fun, but fortunately are not dangerous.
Before a medication is tested on people, it has already been studied extensively in a lab. This enables us to predict well which side effects you might get and we can prepare you for them. It almost never happens that participants suffer from unexpected side effects. For example, an allergic reaction to the medication occurs on average once a year.
Your participation in a clinical trial is always voluntary. You can therefore decide to stop at any time. Sometimes you have to stop. For example because of family circumstances or if the doctor decides it is better for your health. If you stop, we will look at what portion of the compensation you are entitled to. It's only fair!
ICON often conducts trials with medication that is radioactive-labeled. We do that to be able to study how and how quickly the drug is absorbed, processed and eliminated by the body. In a trial with radioactive-labeled medication, you have less of a chance of side effects than in other trials. This is because a much lower dose is administered in these trials. Read more about trials with radioactive-labeled medication.